Medical Device Testing, Characterization & Innovation
Through our materials expertise we offer product and process development and testing and analysis services to medical device manufacturers and suppliers.
We provide medical testing and regulatory support for a wide range of devices and materials across the medical industry. Working to ISO, ASTM and FDA standards (and novel methodologies with rationale when the standards aren't adequate), we offer a one-stop solution to mechanical and chemical testing, consultancy support for regulatory submissions, and materials characterization. Our complete offering is important to our clients as we provide analysis and interpretation of test results, and not just the numbers. Analytical interpretation and rationale support makes regulatory submissions more robust when you are able to clearly demonstrate why you chose your method and show a full understanding of what the results mean for your devices and the end users.
As materials science experts we understand that problems inevitably come down to the material level. Pinpointing when the problem occurs, and how to resolve it, is not always easy. Informed testing, and years of experience, allows us to study any medical device issues and challenges to troubleshoot problems. The same expertise is applied to medical device material characterization and regulatory testing. Devices are complex in geometry, material and chemistry and the standards often need to be thought about carefully to make sure the tests we perform give us the truest evaluation of medical devices in use. This approach is what we at Lucideon have built our reputation on for supporting the successful submission of medical devices to FDA and other regulatory bodies.
Our team comes from varied backgrounds and works closely together to cross fertilize expertise for any given application. As well as medical device specialists with industry experience, we are made up of surface science experts, metallurgists, ceramics and polymer experts, mechanical engineers, materials authorities (e.g. on hydroxyapatite) and many other disciplines.
Our materials knowledge gives us great understanding of their behavior and performance. Your product or material could benefit from the many services we offer, including:
- Biocompatibility - ensure your products are biocompatible and avoid unnecessary in vivo testing
- Quality Control Testing - ensure batch consistency through existing or Lucideon developed protocols
- Powder Processing Consultancy - troubleshoot and optimize processes to create better yields, stability and overall performance including milling, foaming and rheology
- Regulatory Submission Support - generate accurate and complete data to submit to FDA and other authorities
- Cleanliness Validation - develop protocols, validate cleanliness, identify contaminants and understand the significance of changes to your manufacturing process
- Wear and Mechanical Testing - test the durability and robustness of orthopedic implants and other medical devices
- Failure Analysis - identify root causes, solve failures and prevent re-occurrence
- Method Development - we can develop and validate customized methods for all your testing and analysis requirements where industry standards aren’t available
- Additive Manufacturing Support - understand the limitations of your new process and its impact on your product performance, including achieving cleanliness and understanding failure modes
Lucideon's experts sit on a number of relevant committees including: BS committees CH/150 (Implants for Surgery) and CH/150/SC1 (Materials for Surgical Implants) and ISO committees TC 150 (Implants for Surgery), TC 150/SC1 (Materials for Surgical Implants), TC 150/SC1 WG3 (Materials for Surgical Implants – Ceramics), TC 150/SC1 WG3 (Materials for Surgical Implants – Metals), TC 150/SC1 WG3 (Materials for Surgical Implants – Polymers), TC 150 WG7 (Implants for Surgery – Fundamental Standards) and TC 150 WG7 (Implants for Surgery – Coatings).
Materials Development & Technology Innovation
Lucideon has a range of in-house developed technologies that could have perfect applications for you. We work with industry partners to develop our technologies into game changing products for the market.
- Controlled Release Technologies – novel delivery platforms based on glass and ceramic materials to release actives and nutrients in a highly selective and targeted manner
- Bioactive Materials – inorganic ion doping of glasses and ceramics to achieve improved or additional biological responses e.g. antimicrobial
- Toughened Ceramics – a world-first low-energy ceramic processing technology that allows you to control and tailor the microstructure of your ceramics.